On December 4, 2024, Eisai Co., Ltd. and Biogen Inc. announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico approved their humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, LEQEMBI® (lecanemab). This approval is for the treatment of early Alzheimer's disease (AD), encompassing mild cognitive impairment due to AD or mild AD dementia.
LEQEMBI is the first approved treatment demonstrated to reduce the rate of disease progression and slow cognitive and functional decline by selectively binding to soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils). These protofibrils are considered highly toxic and play a primary role in the cognitive decline associated with AD.
The approval in Mexico expands LEQEMBI's global presence, adding to its existing approvals in the U.S., Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain. With approximately 1.3 million people in Mexico estimated to suffer from AD, this regulatory milestone opens a significant new market for Biogen and Eisai, who will co-commercialize and co-promote the product in the country.
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